Comparison of Two Biometers in Dense Cataracts

NCT07475832 | Completed FDA Device

• 1 other identifier: 78171657
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, ambispective, observational study evaluates axial length acquisition in eyes with dense cataracts using the ARGOS swept-source optical coherence tomography biometer compared with the IOLMaster 700. Eligible subjects are pseudophakic adults who previously underwent complex cataract surgery because of poor visualization or poor red reflex from dense lens opacity and who had pre-operative biometry performed with both devices, with or without manual immersion A-scan ultrasonography. Enrolled subjects return for postoperative repeat biometry to confirm pre-operative measurements and to assess whether availability of an ARGOS axial length measurement may reduce the need for manual ultrasound A-scans in similar dense cataract cases. The planned sample size justification estimated that 61 patients were needed for statistical power, while 68 were originally targeted to allow for attrition in the prospective portion.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Percentage of eyes with successful axial length acquisition

  Percentage of eyes in which axial length measurements were successfully acquired using the ARGOS biometer compared with the IOLMaster 700 in eyes with dense cataracts.

  Pre-operative assessment and postoperative confirmation visit, up to 24 months after cataract surgery.

Secondary Outcomes (3)

• Percentage of eyes requiring ultrasound A-scan

  Pre-operative review and postoperative confirmation visit, up to 24 months after cataract surgery.

• Percentage of eyes requiring enhanced retina visualization mode

  Pre-operative review and postoperative confirmation visit, up to 24 months after cataract surgery.

• Difference between postoperative and pre-operative axial length measurements

  Up to 24 months postoperatively.

Study Arms (1)

Eligible pseudophakic subjects with prior dense cataracts

Pseudophakic adult subjects who previously underwent complex cataract surgery because of poor visualization or poor red reflex from dense cataract and who had pre-operative biometry performed with the ARGOS and IOLMaster 700, with or without manual immersion A-scan ultrasonography. Enrolled subjects undergo postoperative repeat biometry for comparison with pre-operative measurements.

Diagnostic Test: ARGOS biometer; Diagnostic Test: IOLMaster 700

Interventions

ARGOS biometer DIAGNOSTIC_TEST

Swept-source optical coherence tomography biometer used for axial length measurement pre-operatively and at the postoperative study visit. Enhanced retina visualization mode may be used when needed.

Eligible pseudophakic subjects with prior dense cataracts

IOLMaster 700 DIAGNOSTIC_TEST

Swept-source optical coherence tomography biometer used for axial length measurement pre-operatively and at the postoperative study visit for comparison with ARGOS measurements.

Eligible pseudophakic subjects with prior dense cataracts

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pseudophakic adults who previously underwent complex cataract surgery for poor red reflex or poor visualization due to dense cataract and had pre-operative biometry with both the ARGOS and IOLMaster 700.

You may qualify if:

• Adults aged 45 years and older
• Previously underwent complex cataract removal by phacoemulsification with a clear corneal incision in one or both eyes more than 1 month before enrollment
• Complex cataract removal was performed for poor red reflex or poor visualization due to lens density or opacification
• Pre-operative dense cataract in the study eye, defined as greater than or equal to 3+ posterior subcapsular cataract, 3+ nuclear sclerotic cataract, 3+ cortical cataract, or any combination of these
• Pre-operative biometry performed with both the ARGOS and IOLMaster 700
• Other than cataract, clear intraocular media, with no corneal opacity or vitreous hemorrhage

You may not qualify if:

• Pre-operative mature or white cataract in the study eye
• Any corneal abnormality, other than regular corneal astigmatism, that in the opinion of the investigator would confound study outcomes
• History of or current retinal condition, or predisposition to retinal conditions, other than posterior vitreous detachment, that in the opinion of the investigator would confound study results
• Amblyopia or strabismus in either eye
• Nystagmus or other condition that would hamper axial length capture because of poor fixation
• History of or current anterior or posterior segment inflammation of any etiology
• Any form of ocular neovascularization
• Diagnosed degenerative eye disorders
• Acute or chronic disease or illness that, in the opinion of the investigator, would confound study results, including immunocompromised state, connective tissue disease, or clinically significant atopic disease

Sponsors & Collaborators

• Berkeley Eye Center: lead
• Alcon Research: collaborator

Study Sites (1)

Berkeley Eye Center - Sugar Land

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 17, 2026
• Study Start: October 11, 2023
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)